Metoclopramide Injection

IMPORTANT WARNING:

Receiving metoclopramide injection may cause you to develop a muscle problem called tardive dyskinesia. If you develop tardive dyskinesia, you will move your muscles, especially the muscles in your face in unusual ways. You will not be able to control or stop these movements. Tardive dyskinesia may not go away even after you stop receiving metoclopramide injection. The longer you receive metoclopramide injection, the greater the risk that you will develop tardive dyskinesia. Therefore, your doctor will probably tell you not to receive metoclopramide injection for longer than 12 weeks. The risk that you will develop tardive dyskinesia is also greater if you are taking medications for mental illness, if you have diabetes, or if you are elderly, especially if you are a woman. Call your doctor immediately if you develop any uncontrollable body movements, especially lip smacking, mouth puckering, chewing, frowning, scowling, sticking out your tongue, blinking, eye movements, or shaking arms or legs.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with metoclopramide injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

Talk to your doctor about the risk of receiving metoclopramide injection.

WHY is this medicine prescribed?

Metoclopramide injection is used to relieve symptoms caused by slow stomach emptying in people who have diabetes. These symptoms include nausea, vomiting, heartburn, loss of appetite, and feeling of fullness that lasts long after meals. Metoclopramide injection is also used to prevent nausea and vomiting caused by chemotherapy or that may occur after surgery. Metoclopramide injection is also sometimes used to empty the intestines during certain medical procedures. Metoclopramide injection is in a class of medications called prokinetic agents. It works by speeding the movement of food through the stomach and intestines.

Are there OTHER USES for this medicine?

Metoclopramide injection is also sometimes used to relieve nausea and vomiting caused by migraine headaches. Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Metoclopramide injection comes as a liquid to be injected into a muscle or into a vein. When metoclopramide injection is used to treat slowed stomach emptying due to diabetes, it may be given up to four times a day. When metoclopramide injection is used to prevent nausea and vomiting due to chemotherapy, it is usually given 30 minutes before the chemotherapy, then once every 2 hours for two doses, then once every 3 hours for three doses. Metoclopramide injection is also sometimes given during surgery. If you are injecting metoclopramide injection at home, inject it at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use metoclopramide injection exactly as directed. Do not inject more or less of it or inject it more often than prescribed by your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before receiving metoclopramide injection,

• tell your doctor and pharmacist if you are allergic to metoclopramide injection, any other medications, or any of the ingredients in metoclopramide injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving metoclopramide injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects..

• the following nonprescription products may interact with metoclopramide injection: allergy medications (diphenhydramine, loratadine, fexofenadine, chlorpheniramine, or cetirizine). Be sure to let your doctor and pharmacist know that you are taking these medications before you start receiving metoclopramide injection. Do not start any of these medications while taking metoclopramide injection without discussing with your healthcare provider.

• tell your doctor if you have or have ever had blockage or bleeding in your stomach or intestines, pheochromocytoma (tumor on a small gland near the kidneys); or seizures. Your doctor will probably tell you not to take metoclopramide.

• tell your doctor if you have or have ever had Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance); high blood pressure; depression; breast cancer; asthma;glucose-6-phosphate dehydrogenase (G-6PD) deficiency (an inherited blood disorder); NADH cytochrome B5 reductase deficiency (an inherited blood disorder); or heart, liver, or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while receiving metoclopramide injection, call your doctor.

• you should know that metoclopramide injection may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

• ask your doctor about the safe use of alcoholic beverages while you are receiving metoclopramide injection. Alcohol can make the side effects from metoclopramide injection worse.

• talk to your doctor about the risks and benefits of receiving metoclopramide injection if you are 65 years of age or older. Older adults should not usually receive metoclopramide injection, unless it is used to treat slow stomach emptying, because it is not as safe or effective as other medications that can be used to treat those conditions.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you are injecting metoclopramide injection at home, inject the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Metoclopramide injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness
• excessive tiredness
• weakness
• headache
• dizziness
• restlessness
• nervousness or jitteriness
• agitation
• difficulty falling asleep or staying asleep
• pacing
• foot tapping
• slow or stiff movements
• blank facial expression
• diarrhea
• nausea
• breast enlargement or discharge
• missed menstrual period
• decreased sexual ability
• frequent urination
• urinary incontinence
• flushing

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• tightening of the muscles, especially in the jaw or neck
• speech problems
• depression
• thinking about harming or killing yourself
• fever
• muscle stiffness
• confusion
• fast, slow, or irregular heartbeat
• sweating
• seizures
• rash
• hives
• swelling of the eyes, face, lips, tongue, mouth, throat, arms, hands, feet, ankles, or lower legs
• difficulty breathing or swallowing
• high-pitched sounds while breathing
• vision problems

Metoclopramide injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Your healthcare provider will tell you how to store your medication. Store your medication only as directed. Make sure you understand how to store your medication properly.

Keep your supplies in a clean, dry place that is out of the reach of children when you are not using them. Your healthcare provider will tell you how to dispose of used needles, syringes, tubing, and containers to avoid accidental injury.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• drowsiness
• confusion
• unusual, uncontrollable movements

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist if you have any questions about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.